Active substanceOxymetazolineOxymetazoline
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  • Dosage form: & nbspnasal dosing spray
    Composition:


    100 ml contains:

    1 dose contains:

    active substance:

    oxymetazoline

    hydrochloride

    0,05 g

    0,025 mg

    Excipients:

    benzalkonium chloride

    0,02 g

    0,01 mg

    camphor racemic

    0,17 g

    0,085 mg

    eucalyptol (cineole)

    0,17 g

    0,085 mg

    levomenthol

    0,17 g

    0,085 mg

    disodium edetate dihydrate

    0,1 g

    0,05 mg

    polysorbate 80

    0.2 g

    0.1 mg

    propylene glycol

    0,006 g

    0,003 g

    sodium hydrogen phosphate dihydrate

    0,65 g

    0,325 g

    acid hydrochloric conc.

    0.003 grams

    0.0015 mg

    purified water

    89.711 g

    44.8555 mg

    Description:
    Transparent liquid from colorless to light yellow color with a weak smell of menthol, eucalyptus and camphor.
    Pharmacotherapeutic group:The anticongestive agent is a vasoconstrictor (alpha-adrenomimetic)
    ATX: & nbsp

    S.01.G.A.04   Oxymetazoline

    Pharmacodynamics:Oksimetazolin belongs to the group of alpha-adrenostimulators for topical application. Has vasoconstrictive effect. With intranasal administration reduces the swelling of the mucous membrane of the upper respiratory tract, which leads to the relief of nasal breathing and the opening of the mouth of the paranasal sinuses and Eustachian tubes. The effect of the drug manifests itself 10-15 minutes after application and lasts for 10-12 hours.
    Indications:To facilitate nasal breathing with "cold" diseases and viral infections of the upper respiratory tract, sinusitis, rhinitis of any etiology.
    Contraindications:Hypersensitivity to the drug or its components, atrophic rhinitis, angle-closure glaucoma, severe atherosclerosis, conditions after transsphenoidal hypophysectomy, simultaneous use of monoamine oxidase inhibitors (including the period of 14 days after their withdrawal), children under 6 years of age, pregnancy, lactation.
    Carefully:
    Patients with diseases of the cardiovascular system (arterial hypertension, coronary heart disease, chronic heart failure, tachycardia, arrhythmias), a violation of carbohydrate metabolism (diabetes mellitus), hyperthyroidism, pheochromocytoma, chronic renal failure, prostatic hyperplasia (urinary retention), with increased intraocular pressure, taking tricyclic antidepressants.
    Pregnancy and lactation:Application during pregnancy and breastfeeding is possible only if the intended benefit to the mother exceeds the possible risk to the fetus or baby.
    Dosing and Administration:

    Intranasally.

    1 dose contains 0.025 mg of oxymetazoline hydrochloride.

    Adults and children over 12 years of age - 2-3 doses in each nasal passage 2 times a day.

    Children from 6 to 12 years old - 1 dose in each nasal passage 2 times a day.

    Do not use the drug more than 2 times a day.

    Duration of treatment:

    It is not recommended to use the drug for more than 3 days. With frequent or prolonged use of the drug, a feeling of difficulty in nasal breathing may reappear or worsen. If these symptoms appear, discontinue treatment and consult a doctor.

    When injecting, do not tilt the head back and do not spray in the "lying" position.

    Side effects:

    Burning or dryness of the mucous membrane of the nasal cavity, dryness in the oral cavity and throat, sneezing, increase in the volume of secret secretion from the nasal cavity. After the effect of using the drug, a strong sense of "stuffiness" of the nose (reactive hyperemia).

    Side effects caused by the systemic effect of the drug: increased blood pressure, headache, dizziness, palpitations, anxiety, nausea, insomnia.

    Benzalkonium chloride, which is part of the drug, can cause irritation of the mucous membrane of the nasal cavity.

    With prolonged use of the drug (more than 7 days) are possible: reactive hyperemia of the mucous membrane of the nasal cavity, atrophy of the mucous membrane of the nasal cavity,tachyphylaxis (rapid reduction of the therapeutic effect with repeated application).

    Overdose:

    In case of an overdose or accidental ingestion of the drug, the following symptoms: nausea, vomiting, cyanosis, fever, tachycardia, arrhythmia, increased blood pressure, dyspnea, mental disorders, central nervous system depression (drowsiness, lower body temperature, bradycardia, lowering blood pressure, stopping breathing and coma).

    Treatment - symptomatic; at casual reception inside - gastric lavage, reception of the activated coal.

    Interaction:When used simultaneously with MAO inhibitors and tricyclic antidepressants, there may be an increase in blood pressure. The drug slows the absorption of local anesthetic drugs, lengthens their action. Co-administration of other vasoconstrictor drugs increases the risk of side effects.
    Special instructions:

    In the recommended dosage without consulting a doctor, use no more than 3 days.

    Avoid contact with eyes. The drug has an effect on vision, possibly reducing the reaction rate.

    To avoid the spread of infection, it is necessary to use the drug individually. With prolonged use (more than one week), it is possible to update the symptoms of nasal congestion.

    Effect on the ability to drive transp. cf. and fur:During treatment, one should refrain from driving vehicles and practicing other potentially hazardous activities requiring increased concentration or speed of psychomotor reactions, as the drug may cause dizziness and other side effects that may affect these abilities.
    Form release / dosage:Spray nasal dosed, 0.025 mg / dose.
    Packaging:

    For 10 ml (150 doses) in a vial of high-density polyethylene with a dispenser, a polypropylene sprayer and a polyethylene protective cap. A label is attached to the bottle.

    The bottle, along with instructions for medical use, is placed in a cardboard box.

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N014631 / 01
    Date of registration:27.12.2007 / 19.05.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:BAYER, AO BAYER, AO Russia
    Manufacturer: & nbsp
    Representation: & nbspBAYER, AOBAYER, AO
    Information update date: & nbsp30.05.2018
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